Hyundai Bio announced on the 4th that it has filed an application with the Ministry of Food and Drug Safety (MFDS) for approval of changes to the Phase 1 clinical trial plan for its prostate cancer treatment 'CP-PCA07.'

[Trial Overview] Phase 1 Multicenter Trial in Combination with Enzalutamide

This clinical trial is an open-label, dose-escalation, multicenter Phase 1 study to evaluate the safety, tolerability, and efficacy of CP-PCA07 administered with enzalutamide in patients with castration-resistant prostate cancer. The trial will be conducted at Seoul Samsung Hospital, Hallym University Sacred Heart Hospital, and Seoul National University Hospital, among others, with a target enrollment of a minimum of 3 and a maximum of 18 subjects.

[Primary Objective] Determining Recommended Phase 2 Dose by Identifying MTD and DLT

The primary objective of the clinical trial is to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) after 12 weeks of administration of enzalutamide and CP-PCA07 in patients with castration-resistant prostate cancer, in order to establish the recommended Phase 2 dose (RP2D). Secondary objectives include assessing changes in prostate-specific antigen (PSA) at time points before and after combination administration, as well as the pharmacokinetic characteristics of niclosamide and its metabolite M1, and enzalutamide.

[Nature of the Amendment] Selection Criteria Revised to Reflect PCWG3 Guidelines

This amendment application is intended to revise the exploratory objectives and selection criteria in accordance with the PCWG3 guidelines and its PSA progression principles. In addition, the trial's operational standards were clarified, including the analysis populations and statistical analysis methods, criteria for dose modification or discontinuation of the investigational medicinal product, the definition of DLT, and detailed determination criteria.

The clinical trial period is approximately 24 months from the date of MFDS approval of the clinical trial protocol. However, the period may be changed depending on factors such as the pace of subject enrollment.

[Patent and Investment Precautions]

Hyundai Bio stated that the intellectual property rights related to this clinical trial, including the patented technology for manufacturing the treatment's formulation, are held by C& Pharm, from which the company has received an exclusive license for the relevant patent-pending technology.

Furthermore, the company noted in its investment precautions that the probability of a clinical trial drug ultimately receiving approval as a medicinal product is statistically known to be around 10%, and that commercialization plans may be changed or abandoned depending on the results of the clinical trial and product approval process.